Fill and Finish Cell Therapy

Abbvie Contract Manufacturing has the leading experts and a global network to scale-up and scale-out drug fill-finish, allogeneic and autologous therapies. Our cGMP manufacturing services deliver excellent operations, customer satisfaction, and future vision for your therapeutic product.

Our state-of-the-art CGMP facilities are both FDA and EMA compliant, offering flexibility and confidence in manufacturing at a worldwide scale. Our expert development and manufacturing teams are sophisticated, and we partner with our gene therapy teams for viral vector production. This brings your cell therapy product from development to industrialization in a seamless process.

Each facility has commercial manufacturing, clinical, and development operations offering full-service capabilities for our client needs. At Abbvie Contract Manufacturing, we excel in various projects, including suspension and adherent cells. 

We have completed several projects as a strategic focus for cell therapy with a cutting-edge fill/finish platform to overcome challenges with allogeneic therapies' scalability. We are always innovating for an accelerated clinical path. 

We have secured the critical manufacturing materials with our vast supply-chain management, which will de-risk your therapeutics. Backed by an expert-led team of scientists and years of success, Abbvie Contract Manufacturing is your go-to for the production of advanced therapeutics.

Fill Finish Manufacturing for Cell Therapy

Currently, manual fill/finish processes have an excellent deterrent for cell therapies' scalability. From manual filling to visual inspection to optimum temperature management and storage conditions, each fill/finish step has its own challenges for manufacturers. 

However, Abbvie Contract Manufacturing has customized the fill/finish services to cell therapy products. Additionally, our team is embarking on endless innovation to maneuver therapies to a readiness state.

Aseptic Fill Finish for Autologous Products

For autologous products, our team carefully considers a multi-step supply chain process to ensure the highest quality standards. Our team manages each detail with precision, from bag filling under strictly regulated aseptic conditions to careful visual inspection of each bag post-fill. 

The bags freeze under temperature-controlled conditions maintained by an impact rate freezer. These bags are put in vapor phase nitrogen freezers offering a long-term storage option for these therapies.

Our team also has a aseptic fill finish platform for allogeneic products to deal with the capacity challenges tied to scaling-up cell products. A closed-vial system developed to ensure container integrity at a below -150°C storage temperature. This efficiency allows us to virtually scale-up allogeneic cell therapies to commercial manufacturing capacity.

Fill Finish Cell Therapy 

Over time, the cell therapy industry has seen tremendous growth thanks to successful CAR-T therapies helping patients with primarily liquid tumors. Learning from CAR-T treatment has led to engineering modifications for the subsequent generation of cell therapy products employing a more comprehensive range of cell types and effective therapies for solid tumors. While the overwhelming majority of the present cell therapy indications focus on oncology, other therapeutic areas like autoimmune, cardiology, and neurology still advance.

While cell therapies accompany promises of a cure, those treatments' event and scalability have their challenges. We understand these challenges and commit to addressing the gaps between autologous and allogeneic cell therapy process development and manufacturing.

We optimize the availability chain to satisfy your specific cell and treatment type requirements and streamline your manufacturing process for optimal cell potency. Our best-in-class manufacturing facilities and scientific know-how give our customers a plus in reducing the complexities of bringing cell therapy to plug faster with commercial readiness.